Biotech Values

[FreeNorth]

Tyme Technologies (TYME) is touting updated survival results from its P2 open-label study of SM-88 "in Subjects With Pancreatic Cancer Whose Disease Has Progressed or Recurred After/on First Line Chemotherapy". TYME favorably contrast the study's current median overall survival of 6.4 months with the historic OS for this patient population of around 2 months. I note, however, that an inclusion requirement for the trial is "life expectancy >3 months, in the judgment of the investigator." Also note that only 38 of 49 patients were included included in the analysis on a per-protocol basis.

From a PR: "Based on these results, TYME plans to initiate a randomized pivotal trial for use of SM-88 in patients with pancreatic cancer in Q3’2019." And from an ESMO poster: "920 mg/day dose has been selected for further evaluation in anticipated future SM-88 pancreatic pivotal registrational trials."